Regulatory Affairs Executive - Ha Noi (8-month Contract)

Purpose:
Responsible for the timely registration of new products of the Business group and the renewal registration of current products.
He/She is expected to regularly visit the regulatory authorities and report on any development that may affect the business. He/She is also be responsible for updating all BCH's regulatory databases.
Scope (global, regional or local):
Conducts technical review and assessment, prepares and submits to the regulatory authorities all pertinent documents related to product registration.
Secures from Global Regulatory Affairs, other Bayer affiliates & from R&D the required documents and materials needed for ensuring local registrations.
Provides regulatory support and guidance to colleagues in their procurement, marketing, sales and manufacturing activities to ensure compliance to relevant internal and external regulations.
Assists marketing in development and documentation of product claims, text and promotional materials to comply with HA regulations.
Develop and foster personal contact within HA and other pertinent agencies.
Conducts competitive intelligence networking of products as necessary. Conducts training on relevant SOPs, Issues and laws, product information as necessary.
Attend to queries related to product information.
Key Tasks:
1. Maintain registration of products intended for local marketing.
2. Coordinates requirements from governmental agencies concerned forproduct initial registration/renewal and documentation.
3. Fulfills medical and pharmaceutical certification, clearance ofreclassification, promotional approval requirements requested by Marketing.
4. Reviews text of local product inserts (PIs), local Artwork in coordination with the internal approvers, consistent with agreed task ownership matrices.
5. Develops objectives and strategies on tasks to ensure implementation and successful achievement of all plans.
6. Formulates together with line manager, individual performance objectives to enhance expertise, technical skills and overall effectiveness.
7. Ensures maintenance and upkeep of all regulatory affairs documents and internal reporting databases such as Brain, Synaps, Doris...
8. Performs other duties required by line manager from time to time.

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Regulatory Affairs, Pharmaceutical Knowledge, Medical, Knowledge In Pharmaceuticals, Regulatory Management